Tuesday, 4 December 2012

HERBALIFE SIDE EFFECTS-1993

Stephen Barrett, M.D.

Herbalife International, of Inglewood, California, markets
weight-control products, dietary supplements, and personal-care
products. The company was founded in 1980 by 24-year-old Mark
Hughes, who states he was inspired by his mother's unsuccessful
struggle to control her weight with amphetamines. However, this
claim was contradicted by an autopsy report which indicyated that
she had died of an overdose of Darvon, a painkiller that is a
controlled dcontradicted by her autopsy. It indicates she died
of an overdose of Darvon, a painkiller classsified as a narcotic
[1].Herbalife's 1993 retail sales totaled $247 million in the United
States and $693 million worldwide. Its principal products are
Formula #1 (a meal-replacement protein drink mix), Formula #2
(an herbal tablet), Formula #3 (a multivitamin/mineral tablet),
and Thermojetics, a weight-control system that includes herbal
tablets. The numbered formula products were originally marketed
as components of Herbalife's Slim and Trim Program. Today the
program is called Herbalife Cellular Nutrition Health and Weight
Management System, and some of the ingredients are different.Hughes dropped out of high school after ninth grade and wound
up in legal difficulty that resulted in his staying for three
years at a residential school for troubled youngsters. When he
was nineteen, his mother died of a drug overdose. According to
a 1985 issue of the Herbalife Journal:

Mark became aware of the need for a safe, effective way to
lose weight . . . when his mother died as a direct result of
following years of unwise dieting practices. This event left
him with a vital interest in nutrition and a fervent desire to
find a product that would enhance and build health while allowing
an individual to take weight off sensibly and safely. . . .During his search, he had met Richard Marconi, Ph.D., with
whom he shared his dream. . . . After a lot of research and testing,
Herbalife Slim and Trim was born.

After working for two multilevel companies that sold weight-control
products but went out of business, Hughes founded Herbalife with
help from Marconi, who had manufactured products for one of these
companies. Herbalife publications describe Marconi as a "well-respected
nutritional expert" and "the leading authority on nutritional
products." His "Ph.D." was obtained from nonaccredited
Donsbach
University after Marconi hooked up with Hughes. After this
fact was brought out at a Congressional hearing (described below),
Herbalife's Journal stopped referring to Marconi as "Dr."Herbalife's initial marketing included lengthy cable television
programs that were filled with financial and health-related testimonials.
Sales were also promoted with buttons and bumper stickers that
said "Lose Weight Now, Ask Me How."In 1982, the FDA sent Herbalife a Notice of Adverse Findings,
which stated that certain products were misbranded because of
labeling claims that they were effective for treating many diseases,
dissolving and removing tumors, rejuvenating, increasing circulation,
and producing mental alertness. A 1984 FDA Talk Paper notes that
the agency had received many complaints about side effects that
had occurred during the use of Herbalife products and had stopped
when use of the products was stopped. In fact, said the Talk Paper,
"Literature given Herbalife distributors states that up to
25% of product users will have adverse effects but claims that
this is evidence of the body's improving itself." Several
suits were filed by people who alleged that the products had harmed
them. Some of these suits were settled out of court with substantial
payment, but the amounts have not been disclosed and the case
records are sealed.

By 1985, Hughes claimed that Herbalife had over 700,000 distributors
and an annual income approaching half a billion dollars a year.
But trouble was brewing. In May 1985, Senator William V. Roth,
Jr. (R-DE) held two days of hearings on weight-reduction programs,
during which he grilled Hughes about the "research and testing"
done prior to marketing Herbalife's products [2,3]. Hughes said,
"We have a lot of scientific data on the herbs," but
Roth ascertained that no actual testing of Herbalife products
had taken place. The hearing also brought to light a study done
by Herbalife of 428 users of its products. About 40% had experienced
headache, constipation, diarrhea, nausea, lightheadedness, palpitations,
and/or other transient symptoms that might be attributable to
Herbalife products. The occurrence of side effects came as no
surprise because several ingredients in Herbalife products were
potent laxatives and one product (N.R.G.) contained guarana, which
is high in caffeine.In March 1985, the California Attorney General had charged
Herbalife with violating California's consumer protection laws.
The suit charged that early editions of the Herbalife Official
Career Handbook made illegal claims that various herbal ingredients
were effective against more than seventy diseases and conditions.
Although most of these claims were deleted in subsequent editions
of the handbook, the company had not replaced the original pages
sent to distributors with the revised pages or asked these distributors
to destroy them. Similar testimonial claims had been made in the
company's cable television broadcasts. The suit also charged that
Herbalife had been operating an illegal pyramid scheme. The case was settled in 1986 when Hughes
and the company agreed to pay $850,000 and to abide by a long
list of court-ordered restrictions on claims and marketing practices.Just before the Senate hearings, Cable News Network aired a
four-part report which revealed that Herbalife's supposed "research
laboratory" was a conference room that housed a large table
and books on herbs, located at one of Marconi's factories. Marconi
told a CNN interviewer, "We employed hundreds . . . even
thousands of Ph.D.s in the research program for our products."
But when asked who they were, he replied, "Why, the research
papers that are published and printed that we have access to on
our computer."

The adverse publicity caused Herbalife's income to drop sharply,
but the company survived, expanded into many foreign countries,
and is now a publicly held corporation. The claims have toned
down and several potentially toxic ingredients have been removed.